As commonly understood, skin or other tissue grafting processes commonly involve the transplanting of a section of tissue to an injury of other anatomical abnormality associated with damage to or a loss of tissue. Some grafting processes involve the transplantation of a section of tissue from one area of a patient to another area of a patient. Other grafting processes; such as allogeneic grafts (where donors and recipients are the same species), xenogeneic grafts (where donors and recipients are different species, such as porcine grafts), and prosthetic grafts (which include synthetic graft materials); can commonly be effectuated by cutting a graft from a sheet of graft material and subsequently applying the cut graft to the intended graft location. Various considerations must be addressed when forming grafts in such a manner.
One consideration to graft preparation relates to providing a sanitary condition associated with the entire process of forming each discrete tissue graft. Failure to properly attend to the sanitation of the process can result in contamination between the various devices associated with the cutting process, the blank materials, as well as already cut graft materials. Still further, inadequate attention to sanitary conditions can result in cross-contamination between already cut grafts, subsequent blank materials, and even subsequent material lots. Accordingly, devices associated with such tissue cutting processes must commonly be disposable and/or constructed to withstand periodic exposure to a suitable sanitation process to mitigate contamination between respective grafts.
Whether provided in a disposable or reusable configuration, another consideration that must be addressed during die formation is the suitability of the materials associated with forming or defining the die as being suitable for exposure to materials or tissues which are ultimately intended to be associated with and supported by a host body. That is, the die assembly and generation of the grafts preferably does not transfer materials that are ill-suited and/or dangerous for biological applications to the grafts.
Another consideration of the press cut generation of tissue grafts relates to providing a graft product that can satisfy generally uniform or repeatable size parameters. In order to press cut graft materials, a cutting edge defined by a press die must be maintained in a generally planar arrangement such that the cutting edge can pass through the graft material in a substantially orthogonal direction relative to the exposed surface plane of the material to generate grafts that are of substantially the same size and which maintain a robust graft edge for subsequent cooperation adjacent tissue of an underlying patient. Movement of the cutting edge relative to an underlying blade support or deviation of the blade during die formation and/or sterilization process can result in a die configuration that is susceptible to incomplete cut operations or undesirable cut profiles. Such shortcomings can detract from a repeatable generation of a uniform graft product and/or decrease the efficiency with which grafts can be created.
Accordingly, it would be desirable to have an assembly and method of forming a press cutting die that is formed of biologically compatible materials, is reusable or disposable, and maintains a cutting edge in a robust manner to maintain the cutting edge at an orientation that is preferably orthogonal to the plane of the tissue to which it is introduced. The present invention discloses an assembly and method of forming such a press cut die.